Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

Roche

Status and phase

Completed

Phase 3

Conditions

HIV Infections

Treatments

Drug: Enfuvirtide

Drug: Optimized background antiretroviral regimen (OB)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02733419

ML18242

Details and patient eligibility

About

This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with HIV-1 infection
Female participants without any risk of pregnancy
Participants previously treated with drugs of 2 or 3 different antiretroviral classes
Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)
Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes
Cluster of differentiation 4 (CD4) cell count greater than (>) 50 cells/cubic millimeter (mm^3) at screening
Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes
Enfuvirtide-naive participants

Exclusion criteria

Women of childbearing age not using effective mechanical contraception
Pregnant or breastfeeding women
Presence of HIV-2 coinfection
Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial
Participants having previously been treated with enfuvirtide
Presence active opportunistic infection within 1 month of study entry
Existence of Grade 4 clinical or laboratory abnormalities
Cirrhosis or severe hepatic failure
Uncontrolled diabetes or requiring insulin
Consumption of alcohol and/or narcotics and/or other substances

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 3 patient groups

Enfuvirtide + OB (Not Randomized)

Experimental group

Description:

Participants will receive enfuvirtide 90 milligram (mg) twice daily (b.i.d.) and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants not meeting the randomization criteria will receive enfuvirtide 90 mg b.i.d and OB for next 24 weeks (up to Week 52).

Treatment:

Drug: Optimized background antiretroviral regimen (OB)

Drug: Enfuvirtide

Enfuvirtide + OB (Randomized)

Experimental group

Description:

Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive enfuvirtide 90 mg b.i.d. and OB for next 24 weeks (up to Week 52).

Treatment:

Drug: Optimized background antiretroviral regimen (OB)

Drug: Enfuvirtide

OB alone (Randomized)

Experimental group

Description:

Treatment:

Drug: Optimized background antiretroviral regimen (OB)

Drug: Enfuvirtide